MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED DRILL BIT LARGE QC/300MM; BIT,DRILL

Catalog Number	310.63
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post-market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, during surgery of the right hip slipped capital femoral epiphysis (scfe) fracture threaded percutaneously with the cannulated screw.During the procedure, the guide wire was placed in the femoral head.The drill was used over the guide wire and during insertion, the tip of the drill bit broke off.Some of the fragments were retrieved in about 5-10 minutes and some were still left in the hip.The procedure was completed successfully.The patient's status was fine.Concomitant device reported: unknown cannulated screw (part # unknown, lot # unknown, quantity 1), unknown guide wire (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) 5.0mm cannulated drill bit large qc/300mm.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM CANNULATED DRILL BIT LARGE QC/300MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9494814
• Report Number: 2939274-2019-62720
• Device Sequence Number: 1542515
• Product Code: HTW
• UDI-Device Identifier: 10886982186812
• UDI-Public: (01)10886982186812
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 310.63
• Device Lot Number: PE04022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 81